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33931
clinical trials with a EudraCT protocol, of which
5497
are clinical trials conducted with subjects less than 18 years old.
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18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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To evaluate the histopathologic response to three 1 mg doses of GX-188E administered by IM injection in combination with EP delivered by TriGrid® in adult females with biopsy-proven HPV16 or 18-associated CIN 2, CIN 2/3 or CIN 3.

E.2.2

Secondary objectives of the trial

To evaluate the virologic response to three 1 mg doses of GX-188E administered by IM injection in combination with EP delivered by TriGrid® in adult females with biopsy-proven HPV 16 or 18-associated CIN 2, CIN 2/3 or CIN 3.

E.2.3

Trial contains a sub-study

No

E.3

Principal inclusion criteria

a. Female subjects age 18-60 years; (only, of Korea age 19-60 years);b. Histologically confirmed HPV-16 or HPV-18-associated CIN 2, CIN 2/3 or CIN 3 from tissue collected less than 10 weeks prior to Vaccination/EP #1 with overall lesion sizes less than 50% of the cervix area and no evidence of invasive cancer in any specimen;c. Colposcopy is satisfactory based on visualization of the entiresquamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area;d. Healthy subjects as judged by the Investigator based on medical history, PE, and normal results for an ECG, CBC, Serum Chemistries, CPK and urinalysis done up to 4 weeks prior to enrolment;e. For women who are not postmenopausal (at least 12 months of nontherapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use a highly effective method of contraception during the treatment period and throughout Week 36 response evaluation visit.Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation,symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.Examples of highly effective contraception include the following:• Combined oral contraceptive pill• Contraceptive transdermal patch• Intrauterine device• Implants for contraception• Injections for contraception (with prolonged release)• Hormonal vaginal device• Sterilization, surgical tubal ligation• Sole sexual partner consisting of surgically sterilized male partnerwith appropriate post-surgical verification of the absence ofspermatozoa in the ejaculate• Double barrier methods: condom and occlusive cap (diaphragm orcervical/vault caps) with spermicidal foam/gel/film/cream/suppository (Note: a female condom and male condom should notbe used together as friction between the two can result in eitherproduct failing)f. Able and willing to comply with all study procedures and voluntarily signs informed consent form.

E.4

Principal exclusion criteria

a. Unsatisfactory colposcopy defined as incomplete visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area;b. Pregnancy or breastfeeding;c. Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site [deltoid, upper arm] (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. All other corticosteroids must be discontinued > 4 weeks prior to Day 0 of study vaccine administration; autoimmune disorders, transplant recipients;d. History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded);e. Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV);f. Administration of any blood product within 3 months of enrollment;g. Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for measles vaccine);h. Participation in a study with an investigational compound or device within 30 days prior to signing informed consent;i. Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);j. History of seizures (unless seizure free for 5 years);k. Tattoos, scars, active lesions/rashes or any implantable leads within 3 cm of the intended site of vaccination/EP;l. Any electronic medical implants (such as cardiac pacemaker);m. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;n. A tendency for severe haemorrhage following acute trauma;o. Prisoners or subjects who are compulsorily detained (involuntarilyincarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;p. Any other conditions judged by the investigator that would limit the evaluation of a subject;q. Previous randomization into this study.

E.5 End points

E.5.1

Primary end point(s)

Histopathological regression of cervical lesions to CIN 1 or less.

E.5.1.1

Timepoint(s) of evaluation of this end point

36 weeks

E.5.2

Secondary end point(s)

Clearance of HPV 16 or 18 in combination with histopathological regression of cervical lesions to CIN 1 or less.

E.5.2.1

Timepoint(s) of evaluation of this end point

36 weeks

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

No

E.6.2

Prophylaxis

No

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

No

E.6.7

Pharmacodynamic

No

E.6.8

Bioequivalence

No

E.6.9

Dose response

No

E.6.10

Pharmacogenetic

No

E.6.11

Pharmacogenomic

No

E.6.12

Pharmacoeconomic

No

E.6.13

Others

No

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

No

E.7.1.1

First administration to humans

No

E.7.1.2

Bioequivalence study

No

E.7.1.3

Other

No

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

No

E.7.4

Therapeutic use (Phase IV)

No

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

No

E.8.1.3

Single blind

No

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

No

E.8.1.7

Other

No

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

No

E.8.2.2

Placebo

Yes

E.8.2.3

Other

No

E.8.2.4

Number of treatment arms in the trial

2

E.8.3

The trial involves single site in the Member State concerned

No

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

3

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

1

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

No

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Georgia

Korea, Republic of

Ukraine

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial

Last visit of the last subject enrolled

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

1

E.8.9.1

In the Member State concerned months

9

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

3

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

No

F.1.1.1

In Utero

No

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

No

F.1.1.3

Newborns (0-27 days)

No

F.1.1.4

Infants and toddlers (28 days-23 months)

No

F.1.1.5

Children (2-11years)

No

F.1.1.6

Adolescents (12-17 years)

No

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

120

F.1.3

Elderly (>=65 years)

No

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

No

F.3 Group of trial subjects

F.3.1

Healthy volunteers

No

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

No

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

No

F.3.3.4

Nursing women

No

F.3.3.5

Emergency situation

No

F.3.3.6

Subjects incapable of giving consent personally

No

F.3.3.7

Others

No

F.4 Planned number of subjects to be included

F.4.1

In the member state

30

F.4.2

For a multinational trial

F.4.2.1

In the EEA

70

F.4.2.2

In the whole clinical trial

120

F.5

Plans for treatment or care after the subject has ended the participation in the trial
(if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned